Archive for Medical Ethics

Stem cell clinics and unapproved, for-profit human experimentation

Editor’s note: I met Dr. Paul Knoepfler online in the wake of my two posts on Gordie Howe and his stem cell treatment for stroke. I was impressed by his posts on the topic and what I saw at his own blog. Given that he’s a stem cell researcher, I wanted him to write a post on stem cell clinics like the one that treated Gordie Howe, and, I’m happy to say, he accepted my invitation and agreed to write this post. I hope to persuade him to write more for us in the future, even though he has his own blog.

When I started blogging in 2010 the stem cell arena was a very different place.

Back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding to continue. The stem cell debate of today, which in its own way is just as fierce as the old one, is focused on how best to regulate the clinical translation and commercialization of innovative stem cell technologies.

The stakes in this new stem cell battle on the regulatory front are very high both for the stem cell field and for patients. Too little regulation could lead to harm to patients and damage to the stem cell field at a crucial juncture in its history, while too much regulation could stifle stem cell and regenerative medicine innovations.

Stem cell clinics should be better-regulated than a Starbucks

Stem cell clinics should be better-regulated than a Starbucks

The goal of stem cell advocates, including myself, is to find a regulatory sweet spot where science-based, innovative stem cell medicine can advance expeditiously. On the other side we have largely physicians and lawyers along with some patients arguing for drastically-reduced regulation and acceleration of for-profit stem cell interventions to patients, even without concrete data supporting safety or efficacy.

The latter group is a key part of a rapidly-proliferating stem cell clinic industry in the US. It consists of for-profit stem cell clinics that collectively have already conducted stem cell transplants on potentially thousands of patients without federal regulatory approval. These clinics have in effect thrown down the gauntlet to the US Food and Drug Administration (FDA) with their use of non-FDA approved stem cell products on patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Science and the Media

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Stem cells versus Gordie Howe’s stroke, part 2


Another Christmas has come and gone, surprisingly fast, as always. I had thought that it might make a good “last of 2014″ post—well, last of 2014 for me, anyway; Harriet and Steve, at least, will be posting before 2014 ends—to do an end of year list of the best and worst of the year. Unfortunately, there remains a pressing issue that doesn’t permit that, some unfinished business, if you will. I’m referring to a story I commented on last week, specifically the credulously-reported story of how 86-year-old hockey legend Gordie Howe is doing a lot better after having undergone an experimental stem cell therapy for his recent stroke. As you might recall at the time, I saw a lot of holes in the story. It turns out that over the last week there have been developments that allow me to fill in some of those holes. Unfortunately, other holes still remain.

First, a brief recap is in order (You can click here for a more detailed timeline). Gordie Howe suffered a massive stroke on October 26, leaving him hemiplegic and with serious speech impairment. Since then, judging from various media reports, he has been slowly improving, although not without significant setbacks. We also know that Howe suffers from significant dementia. Out of the blue, a press release issued on December 19 by the Howe family announced that on December 8 and 9, Gordie Howe “underwent a two-day, non-surgical treatment at Novastem’s medical facility. The treatment included neural stem cells injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2.” His response was described as “truly miraculous,” although, as I pointed out in my post, it’s not clear exactly what “miraculous” meant, given conflicting contemporaneous news accounts before the Howe family press release, particularly his hospitalization from December 1 to 3 for a suspected stroke that turned out to be dehydration.

I noted a number of problems with the story, the first of which is that Howe was clearly not eligible for the clinical trial offered by Stemedica, a company in San Diego that manufactured the stem cells used. Another glaring issue was my inability to locate any description of an actual clinical trial for stroke offered by Novastem. I could find no such trial listed in, and you, our intrepid readers, searched the registry maintained by the Mexican Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and were not able to find any registered clinical trials for stroke being carried out by Clínica Santa Clarita, the clinic Novastem operates. What you, our intrepid readers, did find were trials of stem cells for:

I did the search again over the weekend, and there were no further trials that I could find.

Posted in: Clinical Trials, Medical Ethics, Science and the Media

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Stem cells versus Gordie Howe’s stroke


Note: There is now a major update to this story published here, which explains a lot of the questions remaining in this blog post.

Seven years ago I returned to Michigan, where I was born and spent the first quarter century of my life, after an absence of more than 20 years. In the interim, I had done my surgical residency and earned my PhD in Cleveland, a surgical oncology fellowship in Chicago, and worked in New Jersey at my first academic job for eight and a half years. Then I was lured back with a job in Detroit. One of the odd things about this return after such a long absence was the culture shock, how much I had forgotten about the Detroit area. One of those things that I had forgotten is just how crazy about hockey Michigan, in particular Detroit (meaning the Detroit metropolitan area), is. Detroiters love their Red Wings—love them. Hockey is ingrained in the suburban culture from a very young age, so much so that many Canadians would feel right at home here. Memories of trying and failing to be halfway decent at street hockey and of not being anywhere good enough a skater even to try real hockey as a teen came flooding back to me. (It didn’t help that back then I was approaching six feet tall and weighed only 135 lbs.; “beanpole” didn’t even begin to describe me back then.) In fact, the “cultural center” of the town where I live consists of—I kid you not—a hockey rink and some classrooms that are used for various community functions. No, really, it’s named the city’s Cultural Center.

So it should be no surprise, given how much Detroiters love hockey in general and their Red Wings in particular that it was big news here in late October when Red Wing legend Gordie Howe at age 86 suffered a debilitating stroke that paralyzed the right side of his body, a condition known as hemiplegia. Understandably, there was an outpouring of good wishes for recovery, coupled with retrospectives of Howe’s stellar hockey career. Indeed, I remember that Howe’s condition sounded bad enough from the tenor of the news reports at the time that it seemed likely that he would not survive. But survive he did, and is apparently recovering slowly, with occasional setbacks, such as a recent hospitalization in early December for a suspected “mini-stroke” that turned out to be dehydration and several much smaller strokes before that. The most recent press report I saw before the announcements I’m going to discuss described Howe as on the upswing again.

Then, on Friday, I saw headlines all over the place that were basically similar to this Detroit Free Press headline, “Gordie Howe underwent stem cell clinical trial in Mexico.” The story consisted largely of a press release from Howe’s family that read:

Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Science and the Media

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Eminent Harvard psychologist, mother of positive psychology, New Age quack?

Eminent Harvard psychologist, mother of positive psychology, New Age quack?

Be less curious about people and more curious about ideas.
– Marie Curie’s advice to journalists

langer cbs this

Harvard psychologist Ellen Langer was on CBS This Morning News explaining plans for a psychosocial intervention study with women with Stage IV metastatic breast cancer. The project would attempt to shrink women’s tumors by shifting their mental perspective back to before they were diagnosed.
Seeing her on TV unsettled me because I had just supplied a journalist with quotes for his article in the New York Times about Langer. I hadn’t been following her recently. Instead I focused on her now-famous study from the 70s. Langer had claimed that giving nursing home residents a plant for which they were responsible cut their mortality by half (the nursing home residents, not the plant), compared to residents whose plants were attended by staff. The paper continues to get uncritical coverage in the media and in introductory psychology texts.

I looked up the Timesarticle after seeing CBS This Morning News, and it accurately quoted me:

Posted in: Cancer, Clinical Trials, Medical Ethics

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Legislating Ignorance


Science is under attack, and not just from anti-vaccine celebrities and parents with degrees from Google University. Scientific illiteracy is being woven into the very fabric of our society through legislative assault. If you dismiss this as alarmist hyperbole, you haven’t been paying close enough attention.

Every day thousands of pediatric health care providers throughout the country provide safety advice to patients and their parents during routine health maintenance visits. As part of this important routine we ask a series of standard questions to assess the safety of our patients’ environment. Some of these questions are easy and straightforward, and some are more personal and potentially awkward for patients and their parents, including questions pertaining to sexual practices and preferences and psychosocial history. An important series of questions focuses on potential hazards in the home, such as how toxins and medicines are stored, how pools are secured against curious toddlers, and whether there are guns in the home and how they are stored and secured. Parents are usually appreciative of the advice we provide, and thankful for our concern and attention to these issues. Occasionally patients or parents are taken aback by some of these questions, and very rarely they prefer not to answer them (in my 20 years in practice, I can recall only one time this has occurred). We ask these questions because accidental injuries and deaths are common occurrences in the pediatric population, and there is good evidence that patients tend to follow the advice we provide our patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine

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The false dichotomies of CAM and “integrative medicine”


A lot of medical specialties have throwaway newspapers/magazines that are supported by advertising and somehow mysteriously managed to show up for free in the mailboxes of practitioners. In my case, I’ve found myself on the subscription list for such papers about oncology, but also general surgery (I’m Board-certified as a general surgeon). When I have to recertify in about three years, it will be as a general surgeon, which was really fun to try to do last time after having specialized as a breast cancer surgeon, and will likely be even more fun next time, when I will be 10 years further out from my general surgery and surgical oncology training. In any case, that must be why, no matter where I end up working, sooner or later I end up receiving General Surgery News (GSN).

As throwaway professional newspapers go, GSN is not bad. However, occasionally it publishes op-ed articles that make me scratch my head or even tick me off with their obtuseness. Lately, apparently, it’s started some blogs. The one in particular that is the center of attention for this post is by Victoria Stern, is called “The Scope” and is billed as “exploring the lesser known sides of surgery.” Of course, it’s a bit odd that some of the first posts on this blog are about work hour restrictions and whether they leave new surgeons unprepared to practice surgery, the debate over breast screening, and what it takes to train expert surgeons, none of which are exactly “lesser known sides of surgery.” Work hour restrictions, in particular, have been discussed in surgery journals, at conferences, and among surgeons ad nauseam, particularly whether we are training a generation of surgeons unable to deal with the rigors of practicing surgery in the real world.

Posted in: Critical Thinking, Medical Ethics

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Should the Incidental Discovery of Nonparentage be Disclosed?


“Ummm, I probably shouldn’t be telling you this.”

The July issue of Pediatrics, the official journal of the American Academy of Pediatrics, contains an extremely thought provoking article discussing the risks and benefits of disclosing an incidental finding of nonparentage during pediatric genetic testing. Nonparentage occurs when one, or very rarely both, of the social parents did not serve as source code for a child’s genetic programming, so to speak. Naturally, we aren’t talking about known adoptions but rather when the nonbiological parent is unaware of the fact that they did not contribute an egg or sperm.

Authors Marissa Palmor and Autumn Fiester, both bioethicists at the University of Pennsylvania’s Perelman School of Medicine, take the position of universal nondisclosure when nonparentage is discovered. They acknowledge the pro-disclosure arguments and, in my opinion, successfully rebut them. They go on to make a compelling recommendation for the incorporation of a universal nondisclosure clause into consent forms which states clearly that parental status will not be discussed. (more…)

Posted in: Medical Ethics

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The Truth?

Summertime and the living is easy. I am in Sunriver, Oregon for the week and I though, hilariously, that I would have plenty of time to write a post. Between the hiking, the biking, the golf, the food and the beer, there has been little time to sit in from of a keyboard. There may be no better place to spend a week if you like the outdoors, but they do not have internet on the hike around Paulia Lake. So while a caramel banana cake bakes for a dinner tonight, I have an hour or so churn out a post. Do not expect much.

One person’s ethics is another’s belly laugh, but in medicine ethics are formalized. The basic principles in the US are

  • Respect for autonomy – the patient has the right to refuse or choose their treatment (Voluntas aegroti suprema lex)
  • Beneficence – a practitioner should act in the best interest of the patient (salus aegroti suprema lex)
  • Non-maleficence – “first, do no harm” (primum non nocere)
  • Justice – concerns the distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality).

These are guidelines, not mandated, but if you get an ethics consult in my institutions the above concepts are the framework within which the consult will be completed.

Patients can only be autonomous if they are given accurate, truthful information with which to make a decision about their treatments. You can’t lie to patients, but we all know how you phrase an idea can subtly alter the response. Do you say an 80% success rate or a 20% failure rate? I tend to say both. And not everyone can handle the unvarnished, blunt truth. Part of the art of medicine is trying to tell each patient the truth, the whole truth and nothing but the truth in a manner palatable for the individual patient. It is not easy and I am certain I do not always do a good job. (more…)

Posted in: Medical Ethics, Science and Medicine

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Consortium of Academic Health Centers for Integrative Medicine research conference disappoints even NCCAM

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

In May, the International Research Congress on Integrative Medicine and Health (IRCIMH) conference was held in Miami. In the words of its website, the conference was “convened by” the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM), “in association with” the International Society for Complementary Medicine Research. As CAHCIM chirped in this tweet: “Three days, 22 countries, 100 academic medical institutions, [and] 900 researchers, physicians, educators, and trainees…” Interestingly, despite the fact that “use of all appropriate … healthcare professionals and disciplines to achieve optimal health and healing” is part of CAHCIM’s definition of integrative medicine, actual CAM providers were barely visible among the conference committee bigwigs.

Emmeline Edwards, Ph.D., Director, Division of Extramural Research at the National Center for Complementary and Alternative Medicine (NCCAM), herself on the conference’s Program Committee, was decidedly underwhelmed. (NCCAM helped fund the conference. Additional funding information here.) After offering rather tepid congratulations to the organizers and participants, Dr. Edwards launched into a pointed, but very politely delivered, criticism of the research presented (emphasis mine):

The poster sessions offered a great opportunity to meet many new investigators engaged in exciting research in the field of integrative health. Reflecting on some highlights of these sessions, I was brought to the realization that we could strive for better balance in the science featured in the IRCIMH poster presentations. The clinical research posters outnumbered the basic research presentations 3:1, and research on mind and body strategies dominated the research landscape. One concern is that many clinical research projects were not developed from adequate mechanistic studies and, hence, the outcomes from these projects may not be very informative, provide a well-defined path for the next study, or give direction for future research programs.

How right you are, Dr. Edwards! We’ve been saying some of the same things here at SBM for years. We’ve noticed these very same problems in the organization you work for. Recently, as a matter of fact. (more…)

Posted in: Acupuncture, Basic Science, Clinical Trials, Energy Medicine, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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Dr. Oz and the Terrible, Horrible, No Good, Very Bad Day

Not Dr. Oz's usual television audience

Not Dr. Oz’s usual television audience

Dr. Mehmet Oz is one of the most well-known, and possibly the most influential medical doctor in America. The Dr. Oz Show is broadcast in 118 countries and reaches over 3 million viewers in the USA alone. When Oz profiles a product or supplement on his show, sales explode – it’s called “The Dr. Oz Effect”. Regrettably, Oz routinely and consistently gives questionable health advice, particularly when it comes to weight loss products, where Oz regularly uses hyperbolic terms like “miracle” for the products he profiles:

  • (On green coffee extract) — “You may think magic is make-believe, but this little bean has scientists saying they found the magic weight-loss for every body type.”
  • (On raspberry ketone) — “I’ve got the number one miracle in a bottle to burn your fat”
  • (On Garcinia cambogia) — “It may be the simple solution you’ve been looking for to bust your body fat for good.”

Dr. Oz has profiled so many dubious health strategies that “The Dr. Oz Effect” more accurately refers to the wasted time, effort and finances of any consumer that actually follows his health advice and purchases the steady stream of “miracles” that Oz endorses on his television show. Not surprisingly, Science-Based Medicine is probably Oz’s most persistent and tenacious critic. It’s not just that he’s high profile – it’s that Dr. Oz is a bona fide physician who ought to know better, but chooses to ignore science in favour of hyperbole. It’s the antithesis of what a health professional should be doing. And this is the root of the Oz problem: Oz can give good advice, but he regularly combines it with questionable statements and pseudoscience in a way that the casual viewer can’t distinguish between the science and the fiction. So when Oz calls something a miracle – people listen. Even when miracles show up several times per year. (more…)

Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Politics and Regulation

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